MapLight Receives FDA Fast Track Designation for ML-007C-MA in Alzheimer's Disease Psychosis
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
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Source: Globenewswire
- Fast Track Designation: MapLight Therapeutics announced that its investigational drug ML-007C-MA has received FDA Fast Track designation for treating hallucinations and delusions associated with Alzheimer's disease psychosis, marking a significant milestone in addressing unmet medical needs.
- Clinical Trial Progress: ML-007C-MA demonstrated a favorable safety and tolerability profile in a Phase 1 trial and is currently undergoing a Phase 2 VISTA study, aiming to enroll 300 participants and report topline results in the second half of 2027, further advancing drug development.
- Market Demand: Alzheimer's disease psychosis affects approximately 40% of patients, with symptom occurrence increasing as the disease progresses; the development of ML-007C-MA could significantly improve the quality of life for this population and fill a critical market gap.
- Strategic Implications: This FDA designation not only enhances MapLight's competitiveness in the CNS field but may also expedite the drug's market entry, potentially leading to increased economic returns and market share growth for the company.
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Analyst Views on MPLT
Wall Street analysts forecast MPLT stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MPLT is 31.00 USD with a low forecast of 28.00 USD and a high forecast of 34.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
4 Buy
0 Hold
0 Sell
Strong Buy
Current: 18.580
Low
28.00
Averages
31.00
High
34.00
Current: 18.580
Low
28.00
Averages
31.00
High
34.00
About MPLT
MapLight Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on improving the lives of patients suffering from debilitating central nervous system disorders (CNS). Its lead product candidate, ML-007C-MA, is a fixed-dose combination of an M1/M4 muscarinic agonist, ML-007, co-formulated with a peripherally acting anticholinergic (PAC), which it is initially developing for the treatment of schizophrenia and Alzheimer’s disease psychosis (ADP). ML-007C-MA is designed to activate both M1 and M4 muscarinic receptors in the CNS to drive efficacy, while synchronizing the pharmacokinetics of the agonist and antagonist components to mitigate peripheral cholinergic side effects. Its second product candidate, ML-004, is a 5-HT1B/1D agonist that the Company is developing for the treatment of social communication deficit and/or irritability in autism spectrum disorder. It is also advancing two preclinical programs, ML-021 and ML-009.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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